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July. 08, 2022

Dec. 25, 2022

jRCT2011220011

A Phase 1/2/3, Randomized, Observer-Blind Study of S-268019 in Participants Aged 5 to 11 Years (Part 1)(COVID-19)

A Phase 1/2/3 Study of S-268019 in Participants Aged 5 to 11 Years (Part 1)(COVID-19)

Nagata Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

July. 15, 2022

48

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

prevention purpose

Participant aged 5 to 11 years, at the time of signing the informed consent form (ICF).
Male and female
Capable of giving signed ICF from parent(s) or legal guardian of participant and obtained assent from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF/informed assent form (IA) and in the protocol.

Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection.
Current history of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on other immunosuppressive therapy).
Individuals considered to have hypersensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis).
Participant has a contraindication to intramuscular(IM) injections or blood draws.
Participant weighing under 10 kg

5age 0month 0week old over
12age old not

Both

Prevention of COVID-19

S-268019 (intramuscular injection)

The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, medically-attended AEs (MAAEs), or AEs of special interest (AESIs), vital signs, ECG

Shionogi & Co., Ltd.
Ministry of Health, Labour and Welfare
Not applicable
Hakodate Central General Hospital institutional review board
33-2, Honcho, Hakodate-shi, Hokkaido

+81-138-52-1231

funaki-m@omist.co.jp
Not approval

No

none

History of Changes

No Publication date
2 Dec. 25, 2022 (this page) Changes
1 July. 08, 2022 Detail